CompletedNot Applicable

Effect of Multiple Non-pharmacological Methods for Pain Management During Eye Examination for Retinopathy of Prematurity in Preterm Infants

Turkey (Türkiye)24 participantsStarted 2025-05-01

Plain-language summary

This study will be conducted to determine the effect on pain and vital signs of multiple nonpharmacological methods used in preterm infants during the examination for retinopathy of prematurity (ROP).

Who can participate

Age range

26 Weeks – 32 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Postmenstrual gestational age ≤32 weeks and/or birth weight ≤1500 g, * Stable, awake, in supine position and breathing spontaneously without oxygen support, * Vital signs were within normal limits before the examination, * Premature infants undergoing ROP examination for the first time. Exclusion Criteria: * Preterms who have been administered non-steroidal anti-inflammatory drugs or sedative and antiepileptic drugs such as chloral hydrate, phenobarbital and diazepam within 24 hours before the ROP examination, * Preterms with severe respiratory diseases, receiving respiratory support (continuous positive airway pressure or mechanical ventilation), * Preterms with critical conditions such as central nervous system infections and sepsis, * Preterms with other organic diseases such as severe cardiovascular disease, pulmonary insufficiency, * Preterms with congenital malformations.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Procedural pain score: Premature Infant Pain Profile-Revised Scale (PIPP-R)

Timeframe: 1 minute before the procedure, during the procedure, 2 minutes after the procedure and 5 minutes after the procedure

Trial details

NCT IDNCT06959290

SponsorIstanbul Medeniyet University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-30

View on ClinicalTrials.gov More Premature Infant trials

Who can participate

Age range

26 Weeks – 32 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.